Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal carcinoma

• Metastatic disease

• Not amenable to surgery

• Unidimensionally measurable disease

• No bone metastases

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• WHO 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present)

• SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present)

Renal

• Creatinine no greater than 1.25 times ULN

Cardiac

• No concurrent cardiac abnormalities that would preclude study therapy

Pulmonary

• No concurrent pulmonary abnormalities that would preclude study therapy

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No chronic enteropathy

• No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer

• No concurrent severe uncontrolled infection

• No obstruction or partial obstruction that would interfere with study therapy

• No psychological, social, familial, or geographical situation that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer biological response modifiers

Chemotherapy

• No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago)

• No prior irinotecan

• No prior oxaliplatin

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent anticancer hormonal therapy

Radiotherapy

• At least 4 weeks since prior pelvic radiotherapy

• No prior abdominopelvic radiotherapy

Surgery

• At least 4 weeks since prior surgery

• No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines)

Other

• No other concurrent experimental medication

• No other concurrent anticancer therapy